Futar 119121

GUDID E21711912111

Futar Normal pack

Kettenbach GmbH & Co. KG

Silicone dental impression material

• Primary Device ID: E21711912111
• NIH Device Record Key: 944a97a2-3ad1-4c40-b4ad-aaefa2959713
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Futar
• Version Model Number: 119121
• Catalog Number: 119121
• Company DUNS: 316803246
• Company Name: Kettenbach GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de
• Phone: +4927747050
• Email: info@kettenbach.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E21711912111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081120

FDA Product Code

• ELW: Material, Impression

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-28
• Device Publish Date: 2020-12-18

On-Brand Devices [Futar]

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• E217282781: Futar D Bonus pack
• E217282771: Futar Bonus pack
• E217282761: Futar Fast Bonus pack
• E217282751: Futar Cut & Trim Fast Bonus pack
• E217119761: Futar Cut & Trim Fast Intro pack
• E21711976: Futar Cut & Trim Fast Intro pack
• E217119751: Futar Cut & Trim Fast Normal pack
• E217119711: Futar Scan Normal pack
• E217119701: Futar Scan Sample
• E217119671: Futar D Fast Bulk pack
• E217119611: Futar D Fast Normal pack
• E217119601: Futar D Fast Intro pack
• E217119511: Futar D Slow Normal pack
• E217119401: Futar D Superbulk
• E217119391: Futar D Intro pack
• E217119321: Futar D Normal pack
• E217119281: Futar Clear Fast Normal pack
• E217119271: Futar Fast Bulk pack
• E217119261: Futar Fast Normal pack
• E217119251: Futar Fast Intro pack
• E217119181: Futar Superbulk
• E217119121: Futar Normal pack
• E217119081: Futar Intro pack
• E21728279111: Futar D Fast Bonus pack
• E21728278111: Futar D Bonus pack
• E21728277111: Futar Bonus pack
• E21728276111: Futar Fast Bonus pack
• E21728275111: Futar Cut & Trim Fast Bonus pack
• E21711975111: Futar Cut & Trim Fast Normal pack
• E21711961111: Futar D Fast Normal pack
• E21711951111: Futar D Slow Normal pack
• E21711940111: Futar D Superbulk
• E21711932111: Futar D Normal pack
• E21711926111: Futar Fast Normal pack
• E21711912111: Futar Normal pack
• E2171192411: Futar Easy Fast Normal pack
• E21711923111: Futar Easy Normal pack